AstraZeneca Gets CDSCO Panels Nod to study anticancer drug AZD0901
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the anti-cancer drug AZD0901 powder for solution for infusion.
This came after AstraZeneca presented Phase III clinical study protocol No. D9802C00001 version 1.0 dated 13 October 2023. The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
AZD0901 is a drug being developed by AstraZeneca to treat advanced solid tumors, such as pancreatic cancer, gastric cancer, and adenocarcinoma of the gastroesophageal junction.
AZD0901 specifically targets and binds to CLDN18. 2 expressed on tumor cells. Upon internalization and the release of MMAE, MMAE targets and binds to tubulin, and inhibits microtubule polymerization. This results in G2/M phase cell cycle arrest and apoptosis in CLDN18.
At the recent SEC meeting for Oncology held on 9th October 2024, the expert panel reviewed the Phase III clinical study protocol No. D9802C00001 version 1.0 dated 13 October 2023.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
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